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Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT04272983
Recruitment Status : Completed
First Posted : February 17, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
I.M. Sechenov First Moscow State Medical University

Brief Summary:
To study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies.

Condition or disease
Celiac Disease in Children

Detailed Description:
The purpose of this screening program is to identify people at high risk for developing celiac disease, which is due to the genetic intolerance of gluten - a protein found in wheat, rye and barley. When a person with celiac disease consumes gluten-containing foods, his immune system damages the mucous membrane of the small intestine. Inflammation develops and, as a result, the absorption of vitamins, minerals and other vital nutrients is disrupted. Studies have shown that timely diagnosis of celiac disease is important for the treatment or prevention of its complications. Left untreated, the disease can lead to impaired growth and development, diabetes, cancer, or other diseases. In Europe and the USA, celiac disease is a chronic disease that occurs in approximately one in 100 and one in 22 who have risk factors. There are frequent cases of an erased or low-symptom course of celiac disease. Unfortunately, ninety-seven percent of cases remain undiagnosed and, accordingly, do not receive proper treatment. A screening program will increase knowledge about the disease and contribute to the early detection of the disease.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3070 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Study of the Prevalence of Gluten-dependent Diseases in the Russian Population and the Development of New Biotechnological Approaches to Obtain Gluten-free Products
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease




Primary Outcome Measures :
  1. Questioning of schoolchildren [ Time Frame: 2 year ]
    Questionnaire by specially developed questionnaire. A structured questionnaire was used to collect data on symptoms and signs that are known to be associated with celiac disease. Each of the following statements begin with "Does your child have ...? " Scoring: Never=1; Seldom= 2; Frequent=3; A Lot=4; Don't Know=0; No=1; Yes=2 If the total score was 25 or more, then this respondent belongs to the high risk group for the development of celiac disease.

  2. Serological and genetic studies at risk group [ Time Frame: 3 year ]
    Serological and genetic testing in the laboratory. Screening for celiac disease for suspected celiac disease carried out by testing in an independent laboratory serological examinations (total IgA, AT to tissue transglutaminase IgA, AT to tissue transglutaminase IgG, AT to endomysium IgA); genetic screening - HLA-DQ2 / DQ8; IgE (wheat flour, F4).



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Schoolchildren of the city of Moscow
Criteria

Inclusion Criteria:

  • Schoolchildren from various districts of Moscow selected as a result of questioning in the risk group for the development of celiac disease
  • Availability of written informed consent of the child over 14 years of age to participate in the study;
  • Availability of written informed consent of the parent of the child to participate in the study;
  • Age from 7 to 18 years;
  • Male and female gender;
  • The number of points according to the results of the survey is more than 25.

Exclusion Criteria:

  • Age up to 7 years and over 18 years.
  • The lack of written informed consent of the child over 14 years of age to participate in the study;
  • The lack of written informed consent of the parent / guardian of the child to participate in the study;
  • The number of points on the results of the survey from 0 to 24

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272983


Locations
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Russian Federation
Erdes Svetlana
Moscow, Russian Federation
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
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Study Chair: Svetlana Erdes, Ph.D Sechenov First Moscow State Medical University
Publications:
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Responsible Party: I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT04272983    
Other Study ID Numbers: 16-15-10410
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The local ethics committee does not allow. But upon official request can provide.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases